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HHS/FDA RIN: 0910-AG03 Publication ID: Fall 2007 
Title: ●Defining the Term "Small Numbers of Animals" for Minor Use Designation  
Abstract: The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) (21 U.S.C. 360ccc2, 371) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of “minor use” that relied on the phrase “small numbers of animals” to characterize such use. At this time, FDA is proposing to amend 21 CFR part 516 (the implementing regulations of the MUMS act) to further define “minor use” by defining a specific “small number of animals” for each of the seven major animal species, to be used in determining whether any particular intended use in a major species is a minor use. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 516   
Legal Authority: 21 USC 360ccc2    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/00/2008    
NPRM Comment Period End  08/00/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Bernadette Dunham
Director, Office of Minor Use and Minor Species Animal Drug Development
Department of Health and Human Services
Food and Drug Administration
HFV-101, Center for Veterinary Medicine (HFV-50, MPN-4), Room 180, 7519 Standish Place,
Rockville, MD 20855
Phone:240 276-9000
Fax:240 276-9001
Email: bernadette.dunham@fda.hhs.gov